Photobiomodulation Therapy Versus Integrated Myofascial Release Therapy Techniques In Patients With COVID-19 With Follow-Up Telerehabilitation

NCT06795841 | Completed DMC

• 1 other identifier: FBTBSUREC/2052020
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To compare low-level laser therapy and myofascial release in reducing inflammation and functional recovery in critically ill COVID-19 patients with 3-month home-based telerehabilitation assessment. Participants: One hundred two COVID-19 patients aged 45-60 years randomized into three groups: low-level laser therapy (n=34), myofascial release (n=34), and control (n=34). Intervention: Intensive care unit-based low-level laser therapy, myofascial release, or standard physiotherapy with medical treatment. Following discharge, all participants received 12 weeks of multidimensional home-based telerehabilitation incorporating patient education, breathing exercises, inspiratory muscle training, limb strengthening, aerobic training, and trunk control. Outcomes: Primary outcomes were ferritin and D-dimer levels. Secondary outcomes included C-reactive protein, interleukin-6, white blood cell counts, maximum inspiratory pressure, six-minute walk test, bilateral knee strength, dyspnea perception, fatigue severity, and oxygen saturation. All measured at baseline, discharge, and 3 months. Intensive care unit length of stay and physiotherapy sessions measured at discharge.

Conditions

COVID 19 Disease

Keywords

COVID19; Photobiomodulation; Myofascial release

Outcome Measures

Primary Outcomes (2)

• Lab Investigations

  (1) ferritin

  at baseline and at discharge from ICU up to 14 days and at 3 month of discharge

• lab investigation

  2\. D-dimer

  at baseline and at icu discharge up to 14 days and at 3 months of discharge

Secondary Outcomes (11)

• lab analysis

  at baseline and at ICU discharge up to 14 days and at 3 months of discharge

• lab analysis

  at baseline and at icu discharge up to 14 days and at 3 months of discharge

• lab analysis

  at baseline and at icu discharge up to 14 days and at 3 months of discharge

• Maximum inspiratory pressure

  at baseline and at icu discharge upto 14 days and at 3 months of discharge

• Six-minute walk test

  at baseline and at ICU discharge up to 14 days and at 3 months of discharge

Study Arms (3)

Photobiomodulation therapy

EXPERIMENTAL

Photobiomodulation therapy :Red laser wavelength (630-660 nm), Average power: 50-100 Mw, Dose: 6-10 J/cm2• Area 2-3 minutes/cm2, Sessions: twice -daily, acupuncture Laser Positions: transcutaneous laser therapy

Radiation: Photobiomodulation; Other: telerehabilitation

Myofascial release therapy

EXPERIMENTAL

Myofascial release therapy A- Suboccipital release technique B- anterior cervical myofascial release C- Anterior thoracic and sternal myofascial release D- diaphragmatic dome release technique in addition to traditional physical therapy program

Procedure: Myofascial release therapy; Other: telerehabilitation

traditional physical therapy program

EXPERIMENTAL

included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise for ( strencliedo mastoid ,scalene muscle ,pectorals major and minor ,hamstring and calf muscles )

Device: traditional chest physiotherapy; Other: telerehabilitation

Interventions

Photobiomodulation RADIATION

It was applied for upper respiratory tract over tonsils, trachea, and main bronchi (bilaterally parasternal at the level of angle of Lewis), upper and lower lung, and at cubital vein

Photobiomodulation therapy

Myofascial release therapy PROCEDURE

technique was applied from supine position, with both hands cupping both diaphragmatic domes

Myofascial release therapy

traditional chest physiotherapy DEVICE

included traditional chest physiotherapy (postural drainage, percussion and shaking), stretching exercise

traditional physical therapy program

telerehabilitation OTHER

Following ICU discharge, all patients participated in a 12-week structured home multidimensional telerehabilitation program delivered via videoconferencing (Zoom or Microsoft Teams) under the remote supervision of a physiotherapist. Sessions were conducted three times per week and incorporated patient education, breathing exercises, inspiratory muscle training (30 -50% MIP), strengthening of upper and lower limb muscle groups (50- 70 % 1RM), aerobic training (40- 60% HRR), and trunk control activities. Safety monitoring was emphasized throughout, with patients instructed to use a pulse oximeter before, during, and after each session. Adherence was assessed by session attendance, exercise diaries, and weekly therapist follow-up

Myofascial release therapy; Photobiomodulation therapy; traditional physical therapy program

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The eligibility criteria were as follows:
• Patients aged from 45 to 60 years old.
• Diagnosed by CT or PCR as positive COVID 19.
• Moderate cases of COVID-19(According to CO-RADS Scale).
• On low flow rate oxygen supply

You may not qualify if:

• Patients on Invasive Mechanical Ventilation
• Hemodynamically Unstable with inotropic support
• Septic Shock
• ICU admission less than 24 h
• physician termination of physiotherapy;
• Fever with causes other than chest infection.
• Severe electrolyte imbalance
• Acute Venous Thromboembolism (VTE) without therapeutic anticoagulation for over 48 hours,
• Unstable Atrial fibrillation , or Severe Tachycardia compared to baseline.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of Physical Therapy , Beni-Suef University

Banī Suwayf, 62511, Egypt

Location

Related Publications (1)

• Azadeh SS, Esmaeeli Djavid G, Nobari S, Keshmiri Neghab H, Rezvan M. Light-Based Therapy: Novel Approach to Treat COVID-19. Tanaffos. 2023 Mar;22(3):279-289.

  PMID: 38638386 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Low-Level Light Therapy; Myofascial Release Therapy; Telerehabilitation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Mahmoud Ibrahim Mahmoud, Lecturer

  Faculty of Physical Therapy - Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analyzer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at Faculty of Physical Therapy - Beni-Suef University

Model Details: The intervention group (A) consisted of 34 patients (men and women) who received medical treatment, traditional physiotherapy, and low-level laser therapy; the intervention group (B) consisted of 34 patients ( men and women) who received medical treatment and traditional physiotherapy and myofascial release techniques; and the control group (C) consisted of 34 patients ( men and women ) who received medical treatment and traditional physiotherapy only.After discharge all patients received home multidimension telerehabilitation program for 3 month.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 28, 2025
• Study Start: June 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 31, 2020
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The sharing is available through the study principal investigator ; Prof. Sherin Mehani for about 12 months after publishing the paper.
• Access Criteria: All of the interested readers could access the needed IPD and supportive information upon request through E- mail sherinhassin@yahoo.com

Locations

EG (1)